Austrália - inglês - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - alglucosidase alfa, quantity: 52.5 mg - injection, powder for - excipient ingredients: monobasic sodium phosphate monohydrate; polysorbate 80; mannitol; nitrogen - myozyme (alglucosidase alfa-rch) is indicated for the long-term treatment of patients with a confirmed diagnosis of pompe disease (acid alfa-glucosidase deficiency).

Estados Unidos - inglês - NLM (National Library of Medicine)

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml - lumizyme® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with pompe disease (acid α-glucosidase [gaa] deficiency). none. risk summary data from postmarketing reports and published case reports with alglucosidase alfa use in pregnant women have not identified a lumizyme-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the continuation of treatment for pompe disease during pregnancy should be individualized to the pregnant woman. untreated pompe disease may result in worsening disease symptoms in pregnant women [see clinical considerations] . reproduction studies performed in mice and rabbits at doses resulting in exposures up to 0.4 or 0.5 times the human steady-state auc (area under the plasma concentration-time curve), respectively, during the period of organogenesis revealed no evidence of effects on embryo-fetal development. in mice there was an increase in pup mortality during lactation at maternal exposures 0.4 times the human steady-state auc [see data] . the background risk of major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. pregnant women and women of reproductive potential should be encouraged to enroll in the pompe patient registry. the registry will monitor the effect of lumizyme on pregnant women and their offspring. for more information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500. clinical considerations disease-associated maternal and/or embryo-fetal risk untreated pompe disease has been associated with worsening respiratory and musculoskeletal symptoms in some pregnant women. data animal data all reproductive studies included pretreatment with diphenhydramine to prevent or minimize hypersensitivity reactions. the effects of alglucosidase alfa were evaluated based on comparison to a control group treated with diphenhydramine alone. daily intravenous administration of alglucosidase alfa up to 40 mg/kg in mice and rabbits (0.4 and 0.5 times the human steady-state auc, respectively, at the recommended biweekly dose) during the period of organogenesis had no effects on embryo-fetal development. administration of 40 mg/kg intravenously every other day in mice (0.4 times the human steady-state auc at the recommended biweekly dose) during the period of organogenesis through lactation produced an increase in mortality of offspring during the lactation period. risk summary available published literature suggests the presence of alglucosidase alfa in human milk. there are no reports of adverse effects of alglucosidase alfa on the breastfed infant. there is no information on the effects of alglucosidase alfa on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lumizyme and any potential adverse effects on the breastfed child from lumizyme or from the underlying maternal condition. lactating women with pompe disease treated with lumizyme should be encouraged to enroll in the pompe disease registry [see use in specific populations (8.1)] . clinical considerations a lactating woman may consider interrupting breastfeeding, pumping and discarding breast milk during treatment and for 24 hours after lumizyme administration in order to minimize drug exposure to a breastfed infant. the safety and effectiveness of alglucosidase alfa have been established in pediatric patients with pompe disease [see adverse reactions (6.2)] . the safety and effectiveness of alglucosidase alfa were assessed in 57 treatment-naive infantile-onset pompe disease patients, aged 0.2 month to 3.5 years at first infusion, in three separate clinical trials [see clinical studies (14.1)] . the safety and effectiveness of alglucosidase alfa were assessed in pediatric patients with late (non-infantile) onset pompe disease in a randomized, double-blind, placebo-controlled study in 90 patients, including 2 patients 16 years of age or less [see clinical studies (14.2)] . anaphylaxis, hypersensitivity reactions, and acute cardiorespiratory failure have occurred in pediatric patients [see boxed warning, warnings and precautions (5.1, 5.3)] . additionally, cardiac arrhythmia and sudden cardiac death have occurred in pediatric patients during general anesthesia for central venous catheter placement [see warnings and precautions (5.4)] . the randomized, double-blind, placebo-controlled study of alglucosidase alfa did not include sufficient numbers (n=4) of patients aged 65 years and over to determine whether they respond differently from younger patients [see clinical studies (14.1)] .

Israel - inglês - Ministry of Health

sanofi israel ltd - alglucosidase alfa - powder for concentrate for infusion - alglucosidase alfa 50 mg/vial - alglucosidase alfa - alglucosidase alfa - myozyme is indicated for long-term enzyme replacement therapy (ert) in patients with a confirmed diagnosis of pompe disease (acid alpha-glucosidase deficiency). the benefits of myozyme in patients with late-onset pompe disease have not been established.

Estados Unidos - inglês - NLM (National Library of Medicine)

genzyme corporation - alglucosidase alfa (unii: dti67o9503) (alglucosidase alfa - unii:dti67o9503) - alglucosidase alfa 5 mg in 1 ml

Cingapura - inglês - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - alglucosidase alfa - injection, powder, lyophilized, for solution - 52.5 mg - alglucosidase alfa 50 mg/vial

Grécia - grego - Εθνικός Οργανισμός Φαρμάκων

ΙΦΕΤ ΑΕ - alglucosidase alfa - ΚΟΝΙΣ ΓΙΑ ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ - 50 mg - 0420794050 - alglucosidase alfa - 0.000000

Estados Unidos - inglês - NLM (National Library of Medicine)

genzyme corporation - avalglucosidase alfa (unii: eo144cp0x9) (avalglucosidase alfa - unii:eo144cp0x9) - nexviazyme is indicated for the treatment of patients 1 year of age and older with late-onset pompe disease (lysosomal acid alpha-glucosidase [gaa] deficiency). none. risk summary available data from case reports of nexviazyme use in pregnant women are insufficient to evaluate for a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, available data from postmarketing reports and published case reports on alglucosidase alfa (another hydrolytic lysosomal glycogen-specific enzyme replacement therapy) use in pregnant women have not identified a drug-associated risk of adverse pregnancy outcomes. the continuation of treatment for pompe disease during pregnancy should be individualized to the pregnant woman. untreated pompe disease may result in worsening disease symptoms in pregnant women (see clinical considerations) . embryo-fetal toxicity studies performed in pregnant mice resulted in maternal toxicity related to an immunologic response (including an anaphyl

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - avalglucosidase alfa, quantity: 100 mg - injection, powder for - excipient ingredients: histidine; polysorbate 80; mannitol; histidine hydrochloride monohydrate; glycine - nexviazyme is indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with pompe disease (acid ?-glucosidase deficiency).

União Europeia - maltês - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - mard tal-Ħażna tal-glukoġen tat-tip ii - oħra tal-passaġġ alimentari u tal-metaboliżmu-prodotti, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).

União Europeia - búlgaro - EMA (European Medicines Agency)

sanofi b.v. - avalglucosidase alfa - Гликогенна складова болест тип ii - Други стомашно-чревния тракт и обмяната на веществата средства, - nexviadyme (avalglucosidase alfa) is indicated for long-term enzyme replacement therapy for the treatment of patients with pompe disease (acid α-glucosidase deficiency).